High-performance liquid chromatographic assay for the quantitation of irbesartan (SR 47436/BMS-186295) in human plasma and urine

A selective, accurate, precise and reproducible high-performance liquid chromatographic assay was developed for the quantitation of irbesartan, an angiotensin II antagonist, in human plasma and urine samples. The method involved solid-phase extraction of irbesartan and internal standard (I.S.) using...

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Bibliographic Details
Published in:Journal of chromatography. B, Biomedical sciences and applications Biomedical sciences and applications, 1997-11, Vol.702 (1), p.149-155
Main Authors: Chang, Shu-Ying, Whigan, Daisy B, Vachharajani, Nimish N, Patel, Rajesh
Format: Article
Language:English
Subjects:
Administration, Oral
Analysis
Angiotensin II antagonist
Antihypertensive Agents - administration & dosage
Antihypertensive Agents - analysis
Antihypertensive Agents - chemistry
Antihypertensive Agents - pharmacokinetics
Biological and medical sciences
Biphenyl Compounds - administration & dosage
Biphenyl Compounds - analysis
Biphenyl Compounds - chemistry
Biphenyl Compounds - pharmacokinetics
BMS-186295
Chromatography, High Pressure Liquid - methods
Circadian Rhythm
Drug Stability
General pharmacology
Humans
Irbesartan
Linear Models
Male
Medical sciences
Osmolar Concentration
Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions
Pharmacology. Drug treatments
Reproducibility of Results
Sensitivity and Specificity
SR 47436
Tetrazoles - administration & dosage
Tetrazoles - analysis
Tetrazoles - chemistry
Tetrazoles - pharmacokinetics
Time Factors
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Summary:A selective, accurate, precise and reproducible high-performance liquid chromatographic assay was developed for the quantitation of irbesartan, an angiotensin II antagonist, in human plasma and urine samples. The method involved solid-phase extraction of irbesartan and internal standard (I.S.) using a 100-mg Isolute CN cartridge. A portion of the eluate was injected onto an ODS analytical column connected to a fluorescence detector that was set at an excitation wavelength of 250 nm and an emission wavelength of 371 nm. The mobile phase consisted of 50% acetonitrile and a 50% weak phosphate–triethylamine solution, pH 3.5, at a flow-rate of 0.8 ml/min. The assay was linear from 1 to 1000 ng/ml with both plasma and urine. In either matrix, the lower limit of quantitation was 1 ng/ml. The analyses of quality control samples indicated that the nominal values could be predicted with an accuracy >95%. The inter- and intra-day coefficients of variation for the analyses in both matrices were
ISSN:0378-4347
1387-2273
DOI:10.1016/S0378-4347(97)00387-3